Michael G Woodcock1, Robert Lehmann2, Robert J Cionni2, Michael Breen2, Maria C Scott2. 1. From the Carolina Vision Center (Woodcock), Fayetteville, North Carolina, the Lehmann Eye Center (Lehmann), Nacogdoches, Texas, the Eye Institute of Utah (Cionni), Salt Lake City, Utah, Alcon Laboratories (Breen), Lake Forest, California, and the Cheseapeake Eye Care & Laser Center (Scott), Annapolis, Maryland, USA. Electronic address: lasikpro@gmail.com. 2. From the Carolina Vision Center (Woodcock), Fayetteville, North Carolina, the Lehmann Eye Center (Lehmann), Nacogdoches, Texas, the Eye Institute of Utah (Cionni), Salt Lake City, Utah, Alcon Laboratories (Breen), Lake Forest, California, and the Cheseapeake Eye Care & Laser Center (Scott), Annapolis, Maryland, USA.
Abstract
PURPOSE: To compare astigmatic outcomes in patients with bilateral cataracts having toric intraocular lens (IOL) implantation with intraoperative aberrometry measurements in 1 eye and standard power calculation and a toric IOL calculator with inked axis marking in the contralateral eye. SETTING: Twelve sites in the United States. DESIGN: Prospective cohort study. METHODS: The eye with the more visually significant cataract was randomized to intraoperative aberrometry measurements (Ocular Response Analyzer with Verifeye) or standard preoperative biometry and use of a toric calculator with the contralateral eye automatically assigned to the other group. The primary effectiveness outcome was the proportion of eyes with a postoperative refractive astigmatism of 0.50 diopter (D) or less at 1 month. RESULTS: Of the 130 patients (260 eyes) enrolled, 124 (248 eyes) were randomized; 121 (242 eyes) completed the trial. The percentage of eyes with astigmatism of 0.50 D or less at 1 month was higher in the intraoperative aberrometry group than in the standard group (89.2% versus 76.6%) (P = .006). The mean postoperative refractive astigmatism was lower in the intraoperative aberrometry group (0.29 D ± 0.28 [SD] versus 0.36 ± 0.35 D) (P = .041). Secondary effectiveness endpoints, including manifest refraction spherical equivalent prediction error, uncorrected distance visual acuity, and corrected distance visual acuity, were similar. CONCLUSIONS: Compared with standard methods, the use of the intraoperative aberrometry system increased the proportion of eyes with postoperative refractive astigmatism of 0.50 D or less and reduced the mean postoperative refractive astigmatism at 1 month. Other efficacy outcomes were similar. FINANCIAL DISCLOSURES: Drs. Woodcock, Lehmann, and Cionni are consultants to Alcon Laboratories, Inc. Dr. Breen is an employee of Alcon Laboratories, Inc. Dr. Scott has no financial or proprietary interest in any material or method mentioned.
RCT Entities:
PURPOSE: To compare astigmatic outcomes in patients with bilateral cataracts having toric intraocular lens (IOL) implantation with intraoperative aberrometry measurements in 1 eye and standard power calculation and a toric IOL calculator with inked axis marking in the contralateral eye. SETTING: Twelve sites in the United States. DESIGN: Prospective cohort study. METHODS: The eye with the more visually significant cataract was randomized to intraoperative aberrometry measurements (Ocular Response Analyzer with Verifeye) or standard preoperative biometry and use of a toric calculator with the contralateral eye automatically assigned to the other group. The primary effectiveness outcome was the proportion of eyes with a postoperative refractive astigmatism of 0.50 diopter (D) or less at 1 month. RESULTS: Of the 130 patients (260 eyes) enrolled, 124 (248 eyes) were randomized; 121 (242 eyes) completed the trial. The percentage of eyes with astigmatism of 0.50 D or less at 1 month was higher in the intraoperative aberrometry group than in the standard group (89.2% versus 76.6%) (P = .006). The mean postoperative refractive astigmatism was lower in the intraoperative aberrometry group (0.29 D ± 0.28 [SD] versus 0.36 ± 0.35 D) (P = .041). Secondary effectiveness endpoints, including manifest refraction spherical equivalent prediction error, uncorrected distance visual acuity, and corrected distance visual acuity, were similar. CONCLUSIONS: Compared with standard methods, the use of the intraoperative aberrometry system increased the proportion of eyes with postoperative refractive astigmatism of 0.50 D or less and reduced the mean postoperative refractive astigmatism at 1 month. Other efficacy outcomes were similar. FINANCIAL DISCLOSURES: Drs. Woodcock, Lehmann, and Cionni are consultants to Alcon Laboratories, Inc. Dr. Breen is an employee of Alcon Laboratories, Inc. Dr. Scott has no financial or proprietary interest in any material or method mentioned.